[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.77]

[Page 240]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
  Subpart E_Requirement to Establish a Production and Process Control 
                                 System
 
Sec.  111.77  What must you do if established specifications are not met?

    (a) For specifications established under Sec.  111.70(a), (b)(2), 
(b)(3), (c), (d), (e), and (g) that you do not meet, quality control 
personnel, in accordance with the requirements in subpart F of this 
part, must reject the component, dietary supplement, package or label 
unless such personnel approve a treatment, an in-process adjustment, or 
reprocessing that will ensure the quality of the finished dietary 
supplement and that the dietary supplement is packaged and labeled as 
specified in the master manufacturing record. No finished batch of 
dietary supplements may be released for distribution unless it complies 
with Sec.  111.123(b).
    (b) For specifications established under Sec.  111.70(b)(1) that you 
do not meet, quality control personnel must reject the component and the 
component must not be used in manufacturing the dietary supplement.
    (c) For specifications established under Sec.  111.70(f) that you do 
not meet, quality control personnel must reject the product and the 
product may not be packaged or labeled for distribution as a dietary 
supplement.